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Clinical Trial Results:
A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV). The study is also known as Aliskiren Trial of Minimizing OutcomeS in Patients with HEart failure (ATMOSPHERE).

Summary
EudraCT number	2008-004104-31
Trial protocol	AT DE SK NL FI SE DK LT BE PT IT IE ES CZ PL FR LV GB EE GR
Global end of trial date	05 Oct 2015

Results information
Results version number	v1(current)
This version publication date	20 Oct 2016
First version publication date	20 Oct 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CSPP100F2301

ISRCTN number

-

US NCT number

NCT00853658

WHO universal trial number (UTN)

-

Sponsor organisation name

Novartis Pharma AG

Sponsor organisation address

CH-4002, Basel, Switzerland,

Public contact

Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,

Scientific contact

Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

05 Oct 2015

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

05 Oct 2015

Was the trial ended prematurely?

No

Main objective of the trial

The primary objectives of ATMOSPHERE were firstly to test whether the combination of aliskiren and enalapril is superior to enalapril monotherapy in delaying time to the first occurrence of CV death or HF hospitalization in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction, and secondly to test whether aliskiren monotherapy is superior, or at least non-inferior, to enalapril monotherapy using the same composite endpoint. The superiority comparison of the combination of aliskiren and enalapril versus enalapril monotherapy in patients without diabetes at baseline was added to the primary objectives through protocol amendment #4, in April 2013.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

13 Mar 2009

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 41

Country: Number of subjects enrolled

Austria: 59

Country: Number of subjects enrolled

Belgium: 73

Country: Number of subjects enrolled

Brazil: 201

Country: Number of subjects enrolled

Canada: 77

Country: Number of subjects enrolled

China: 465

Country: Number of subjects enrolled

Colombia: 145

Country: Number of subjects enrolled

Costa Rica: 17

Country: Number of subjects enrolled

Czech Republic: 307

Country: Number of subjects enrolled

Denmark: 253

Country: Number of subjects enrolled

Dominican Republic: 23

Country: Number of subjects enrolled

Argentina: 501

Country: Number of subjects enrolled

Estonia: 47

Country: Number of subjects enrolled

Finland: 24

Country: Number of subjects enrolled

France: 34

Country: Number of subjects enrolled

Germany: 469

Country: Number of subjects enrolled

United Kingdom: 48

Country: Number of subjects enrolled

Greece: 59

Country: Number of subjects enrolled

India: 782

Country: Number of subjects enrolled

Ireland: 16

Country: Number of subjects enrolled

Italy: 286

Country: Number of subjects enrolled

Japan: 210

Country: Number of subjects enrolled

Korea, Republic of: 143

Country: Number of subjects enrolled

Latvia: 65

Country: Number of subjects enrolled

Lithuania: 61

Country: Number of subjects enrolled

Mexico: 50

Country: Number of subjects enrolled

Netherlands: 162

Country: Number of subjects enrolled

Norway: 22

Country: Number of subjects enrolled

Peru: 116

Country: Number of subjects enrolled

Poland: 302

Country: Number of subjects enrolled

Portugal: 54

Country: Number of subjects enrolled

Romania: 290

Country: Number of subjects enrolled

Russian Federation: 554

Country: Number of subjects enrolled

Slovakia: 327

Country: Number of subjects enrolled

South Africa: 52

Country: Number of subjects enrolled

Spain: 142

Country: Number of subjects enrolled

Sweden: 141

Country: Number of subjects enrolled

Switzerland: 15

Country: Number of subjects enrolled

Taiwan: 113

Country: Number of subjects enrolled

Thailand: 56

Country: Number of subjects enrolled

Turkey: 70

Country: Number of subjects enrolled

United States: 116

Country: Number of subjects enrolled

Venezuela, Bolivarian Republic of: 76

Worldwide total number of subjects

7064

EEA total number of subjects

3241

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

3605

From 65 to 84 years

3357

85 years and over

102

Subject disposition

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Recruitment details

-

Screening details

During Active Run-in period, patients received enalapril for step 1 & 2 and then aliskiren on top of the max tolerated dose of enalapril for step 3. Patients who completed the run in were randomized in a 1:1:1 ratio to one of the 3 treatment arms (aliskiren/enalapril combination therapy, aliskiren monotherapy, or enalapril monotherapy).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Monitor, Carer, Subject, Data analyst, Assessor

Are arms mutually exclusive

Yes

Combination Aliskiren / Enalapril

Arm description

Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.

Arm type

Experimental

Investigational medicinal product name

Aliskiren

Investigational medicinal product code

SPP100

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Aliskiren 150 mg titrated to 300 mg oral film-coated tablet daily.

Investigational medicinal product name

Enalapril

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Enalapril 10 mg oral film-coated tablet daily.

Aliskiren

Arm description

Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.

Arm type

Experimental

Investigational medicinal product name

Aliskiren

Investigational medicinal product code

SPP100

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Aliskiren 150 mg titrated to 300 mg oral film-coated tablet daily.

Enalapril

Arm description

Enalapril monotherapy -10 mg film-coated tablet and administered orally.

Arm type

Active comparator

Investigational medicinal product name

Enalapril

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Enalapril 10 mg oral film-coated tablet daily.

Number of subjects in period 1	Combination Aliskiren / Enalapril	Aliskiren	Enalapril
Started	2354	2356	2354
Full Analysis Set (FAS)	2340	2340	2336
Safety Set	2347	2348	2345
Completed	1567	1524	1539
Not completed	787	832	815
Vital Status known (alive) at study end	2	3	3
Death	713	768	753
H.A. Request	26	23	19
Vital Status at study end N/A	8	10	10
IRB request	-	-	2
Lost to follow-up	11	6	11
Vital Status unknown at study end	1	1	-
Patient's request	21	17	11
Missing study completion information	5	4	6

Baseline characteristics

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Reporting group title

Combination Aliskiren / Enalapril

Reporting group description

Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.

Reporting group title

Aliskiren

Reporting group description

Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.

Reporting group title

Enalapril

Reporting group description

Enalapril monotherapy -10 mg film-coated tablet and administered orally.

Reporting group values	Combination Aliskiren / Enalapril	Aliskiren	Enalapril	Total
Number of subjects	2354	2356	2354	7064
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	0	0	0	0
Adults (18-64 years)	1219	1185	1201	3605
From 65-84 years	1099	1130	1128	3357
85 years and over	36	41	25	102
Age Continuous
Units: years
arithmetic mean (standard deviation)	63.2 ( 11.65 )	63.3 ( 12.06 )	63.3 ( 11.71 )	-
Gender, Male/Female
Units: Subjects
Male	1857	1822	1850	5529
Female	497	534	504	1535

End points

Top of page

Reporting group title

Combination Aliskiren / Enalapril

Reporting group description

Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.

Reporting group title

Aliskiren

Reporting group description

Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.

Reporting group title

Enalapril

Reporting group description

Enalapril monotherapy -10 mg film-coated tablet and administered orally.

Primary: Number of participants that had first occurrence of the composite endpoint, which is defined as either Cardiovascular (CV) death or Heart Failure (HF) hospitalization

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End point title

Number of participants that had first occurrence of the composite endpoint, which is defined as either Cardiovascular (CV) death or Heart Failure (HF) hospitalization

End point description

Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.

End point type

Primary

End point timeframe

up to End of Study (78 months)

End point values	Combination Aliskiren / Enalapril	Aliskiren	Enalapril
Number of subjects analysed	2340	2340	2336
Units: participants
Primary Composite	770	791	808
CV death	512	562	547
1st HF Hospitalization	430	442	452

Superiority Statistical Analysis

Statistical analysis description

Superiority of Combination Aliskiren / Enalapril versus Enalapril monotherapy

Comparison groups

Combination Aliskiren / Enalapril v Enalapril

Number of subjects included in analysis

4676

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1724

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

1.03

Superiority Non-Diabetic patients

Statistical analysis description

Superiority of Combination Aliskiren / Enalapril versus Enalapril monotherapy Non-Diabetic patients

Comparison groups

Combination Aliskiren / Enalapril v Enalapril

Number of subjects included in analysis

4676

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4579

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

1.07

Non-Inferiority Statistical Analysis

Statistical analysis description

Non-Inferiority Statistical Analysis of Aliskiren monotherapy versus Enalapril monotherapy

Comparison groups

Aliskiren v Enalapril

Number of subjects included in analysis

4676

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[1]

P-value

= 0.0368

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.9

upper limit

1.1

Notes
[1] - Pre-specified Non-inferiority margin 1.104 is used.

Superiority Statistical Analysis

Statistical analysis description

Superiority Statistical Analysis of Aliskiren monotherapy versus Enalapril monotherapy

Comparison groups

Aliskiren v Enalapril

Number of subjects included in analysis

4676

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.9118

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.9

upper limit

1.1

Secondary: Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score

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End point title

Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score

End point description

Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

End point type

Secondary

End point timeframe

Baseline, Month 12

End point values	Combination Aliskiren / Enalapril	Aliskiren	Enalapril
Number of subjects analysed	2340	2340	2336
Units: KCCQ Score
least squares mean (standard error)	-5.04 ( 0.56 )	-6.03 ( 0.57 )	-5.01 ( 0.55 )

No statistical analyses for this end point

Secondary: All Cause Death

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End point title

All Cause Death

End point description

Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.

End point type

Secondary

End point timeframe

up to end of study (78 months)

End point values	Combination Aliskiren / Enalapril	Aliskiren	Enalapril
Number of subjects analysed	2340	2340	2336
Units: participants	595	654	646

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.1

Reporting group title

Combination

Reporting group description

Combination

Reporting group title

Aliskiren

Reporting group description

Aliskiren

Reporting group title

Enalapril

Reporting group description

Enalapril

Serious adverse events	Combination	Aliskiren	Enalapril
Total subjects affected by serious adverse events
subjects affected / exposed	1466 / 2347 (62.46%)	1504 / 2348 (64.05%)	1501 / 2345 (64.01%)
number of deaths (all causes)	349	403	392
number of deaths resulting from adverse events	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adenocarcinoma gastric
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adenocarcinoma of appendix
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	3 / 2347 (0.13%)	8 / 2348 (0.34%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adrenal adenoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	2 / 2347 (0.09%)	5 / 2348 (0.21%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign ear neoplasm
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign lung neoplasm
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign neoplasm of bladder
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign neoplasm of skin
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign neoplasm of spinal cord
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign neoplasm of thyroid gland
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign pancreatic neoplasm
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign renal neoplasm
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign salivary gland neoplasm
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bile duct adenocarcinoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bile duct cancer
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	3 / 2347 (0.13%)	4 / 2348 (0.17%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 3	0 / 5	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder cancer recurrent
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder papilloma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bone cancer
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain neoplasm malignant
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast cancer female
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchial carcinoma
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	7 / 2345 (0.30%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carcinoma in situ of penis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carcinoma in situ of skin
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac valve fibroelastoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebellar tumour
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 8	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colon adenoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	10 / 2347 (0.43%)	4 / 2348 (0.17%)	7 / 2345 (0.30%)
occurrences causally related to treatment / all	0 / 10	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colon cancer metastatic
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colon cancer recurrent
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Extranodal marginal zone B-cell lymphoma (MALT type)
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gallbladder cancer
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric adenoma
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	6 / 2347 (0.26%)	3 / 2348 (0.13%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal cancer metastatic
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal carcinoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Glioblastoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Glioma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemangioma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	4 / 2347 (0.17%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic cancer metastatic
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic neoplasm
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary cancer
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatocellular carcinoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hodgkin's disease
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypopharyngeal cancer
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infected neoplasm
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal adenocarcinoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Keratoacanthoma
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large intestine benign neoplasm
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laryngeal squamous cell carcinoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lentigo maligna
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lip and/or oral cavity cancer
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lip neoplasm malignant stage unspecified
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lipoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung adenocarcinoma metastatic
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung cancer metastatic
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung carcinoma cell type unspecified stage IV
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung neoplasm
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	9 / 2347 (0.38%)	9 / 2348 (0.38%)	12 / 2345 (0.51%)
occurrences causally related to treatment / all	0 / 9	0 / 9	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant neoplasm of auricular cartilage
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant neoplasm of renal pelvis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant palate neoplasm
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant pleural effusion
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mediastinum neoplasm
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meningioma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to bone marrow
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to central nervous system
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to liver
subjects affected / exposed	0 / 2347 (0.00%)	7 / 2348 (0.30%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to lung
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to lymph nodes
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to peritoneum
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to pleura
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastases to spine
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastatic malignant melanoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastatic pain
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastatic squamous cell carcinoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myeloproliferative disorder
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nasopharyngeal cancer
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neoplasm malignant
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neuroendocrine carcinoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-Hodgkin's lymphoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-small cell lung cancer stage IV
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	3 / 2347 (0.13%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ovarian cancer
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	4 / 2347 (0.17%)	2 / 2348 (0.09%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 6	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatic carcinoma metastatic
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatic carcinoma stage IV
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Penile cancer
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pineal parenchymal neoplasm malignant
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	5 / 2347 (0.21%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pleural mesothelioma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	6 / 2347 (0.26%)	7 / 2348 (0.30%)	19 / 2345 (0.81%)
occurrences causally related to treatment / all	1 / 6	0 / 8	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatic adenoma
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectosigmoid cancer
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	5 / 2347 (0.21%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal cancer metastatic
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	2 / 2347 (0.09%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 2	2 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal neoplasm
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Salivary gland adenoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinus cancer metastatic
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin cancer
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small cell lung cancer recurrent
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyroid cancer
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyroid neoplasm
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tongue neoplasm malignant stage unspecified
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tumour flare
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tumour haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tumour pain
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Accelerated hypertension
subjects affected / exposed	5 / 2347 (0.21%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aneurysm ruptured
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	0 / 2347 (0.00%)	8 / 2348 (0.34%)	8 / 2345 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic aneurysm rupture
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic arteriosclerosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic dilatation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic dissection
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic rupture
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic thrombosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arterial insufficiency
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arterial stenosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arterial thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arteriosclerosis
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arteriovenous fistula
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arteritis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bleeding varicose vein
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	7 / 2347 (0.30%)	3 / 2348 (0.13%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	2 / 7	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	3 / 2347 (0.13%)	5 / 2348 (0.21%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic vascular disorder
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Embolism arterial
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Embolism venous
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femoral artery embolism
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femoral artery occlusion
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematoma
subjects affected / exposed	5 / 2347 (0.21%)	1 / 2348 (0.04%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemodynamic instability
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertension
subjects affected / exposed	17 / 2347 (0.72%)	13 / 2348 (0.55%)	10 / 2345 (0.43%)
occurrences causally related to treatment / all	0 / 19	1 / 13	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	7 / 2347 (0.30%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypotension
subjects affected / exposed	37 / 2347 (1.58%)	49 / 2348 (2.09%)	26 / 2345 (1.11%)
occurrences causally related to treatment / all	9 / 38	18 / 52	9 / 34
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	1 / 2347 (0.04%)	4 / 2348 (0.17%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Iliac artery embolism
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Iliac artery occlusion
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	5 / 2347 (0.21%)	5 / 2348 (0.21%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic limb pain
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	5 / 2347 (0.21%)	3 / 2348 (0.13%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	1 / 5	1 / 3	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	18 / 2347 (0.77%)	13 / 2348 (0.55%)	11 / 2345 (0.47%)
occurrences causally related to treatment / all	0 / 22	0 / 15	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral artery aneurysm
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral artery stenosis
subjects affected / exposed	5 / 2347 (0.21%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral embolism
subjects affected / exposed	4 / 2347 (0.17%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 4	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	5 / 2347 (0.21%)	8 / 2348 (0.34%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral venous disease
subjects affected / exposed	0 / 2347 (0.00%)	4 / 2348 (0.17%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 0	1 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post thrombotic syndrome
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Secondary hypertension
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Shock
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Shock haemorrhagic
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subclavian artery stenosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombophlebitis superficial
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Varicophlebitis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Varicose ulceration
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Varicose vein
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular rupture
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Venous haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Venous thrombosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Heart transplant
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Implantable defibrillator insertion
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Abasia
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Accidental death
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Asthenia
subjects affected / exposed	8 / 2347 (0.34%)	5 / 2348 (0.21%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 8	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain death
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac complication associated with device
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac death
subjects affected / exposed	51 / 2347 (2.17%)	68 / 2348 (2.90%)	87 / 2345 (3.71%)
occurrences causally related to treatment / all	0 / 51	1 / 68	1 / 87
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chest pain
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Death
subjects affected / exposed	75 / 2347 (3.20%)	84 / 2348 (3.58%)	82 / 2345 (3.50%)
occurrences causally related to treatment / all	1 / 75	0 / 84	0 / 82
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device battery issue
subjects affected / exposed	13 / 2347 (0.55%)	9 / 2348 (0.38%)	14 / 2345 (0.60%)
occurrences causally related to treatment / all	0 / 13	0 / 9	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device breakage
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device defective
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device dislocation
subjects affected / exposed	1 / 2347 (0.04%)	4 / 2348 (0.17%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device electrical impedance issue
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device end of service
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device failure
subjects affected / exposed	4 / 2347 (0.17%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device inappropriate shock delivery
subjects affected / exposed	1 / 2347 (0.04%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device issue
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device lead damage
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device lead issue
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	7 / 2347 (0.30%)	10 / 2348 (0.43%)	9 / 2345 (0.38%)
occurrences causally related to treatment / all	0 / 7	0 / 10	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device signal detection issue
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device stimulation issue
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Disease progression
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Drug withdrawal syndrome
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Exercise tolerance decreased
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fatigue
subjects affected / exposed	5 / 2347 (0.21%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 5	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Feeling abnormal
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	3 / 2347 (0.13%)	3 / 2348 (0.13%)	7 / 2345 (0.30%)
occurrences causally related to treatment / all	0 / 3	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Generalised oedema
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hernia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypothermia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ill-defined disorder
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Implant site erosion
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Implant site haemorrhage
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Implant site necrosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Implant site pain
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Implant site ulcer
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Incarcerated hernia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Inflammation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Influenza like illness
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury associated with device
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lead dislodgement
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Localised oedema
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malaise
subjects affected / exposed	5 / 2347 (0.21%)	4 / 2348 (0.17%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 6	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Medical device complication
subjects affected / exposed	4 / 2347 (0.17%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Medical device site thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metaplasia
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Multi-organ failure
subjects affected / exposed	21 / 2347 (0.89%)	15 / 2348 (0.64%)	12 / 2345 (0.51%)
occurrences causally related to treatment / all	0 / 21	0 / 15	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Necrosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	13 / 2347 (0.55%)	15 / 2348 (0.64%)	22 / 2345 (0.94%)
occurrences causally related to treatment / all	0 / 15	0 / 16	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oedema
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	9 / 2347 (0.38%)	6 / 2348 (0.26%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 13	1 / 7	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Organ failure
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	5 / 2347 (0.21%)	8 / 2348 (0.34%)	7 / 2345 (0.30%)
occurrences causally related to treatment / all	0 / 5	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Stent-graft endoleak
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	38 / 2347 (1.62%)	39 / 2348 (1.66%)	50 / 2345 (2.13%)
occurrences causally related to treatment / all	2 / 38	5 / 39	3 / 50
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sudden death
subjects affected / exposed	98 / 2347 (4.18%)	89 / 2348 (3.79%)	86 / 2345 (3.67%)
occurrences causally related to treatment / all	0 / 98	0 / 89	1 / 86
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombosis in device
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ulcer
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ulcer haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Undersensing
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular stent restenosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular stent stenosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular stent thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune system disorders
Allergy to venom
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Heart transplant rejection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transplant rejection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Social circumstances
Immobile
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Treatment noncompliance
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Acquired hydrocele
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Benign prostatic hyperplasia
subjects affected / exposed	2 / 2347 (0.09%)	9 / 2348 (0.38%)	7 / 2345 (0.30%)
occurrences causally related to treatment / all	0 / 2	0 / 10	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast hyperplasia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mammary fistula
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Menorrhagia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metrorrhagia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postmenopausal haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatic obstruction
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatomegaly
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectocele
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Scrotal oedema
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spermatocele
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	20 / 2347 (0.85%)	20 / 2348 (0.85%)	17 / 2345 (0.72%)
occurrences causally related to treatment / all	0 / 24	2 / 25	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	13 / 2347 (0.55%)	8 / 2348 (0.34%)	14 / 2345 (0.60%)
occurrences causally related to treatment / all	0 / 15	0 / 12	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alveolitis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Apnoea
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Asphyxia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed	4 / 2347 (0.17%)	8 / 2348 (0.34%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	1 / 4	0 / 11	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Asthmatic crisis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis chronic
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	8 / 2345 (0.34%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchopleural fistula
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cheyne-Stokes respiration
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	32 / 2347 (1.36%)	32 / 2348 (1.36%)	43 / 2345 (1.83%)
occurrences causally related to treatment / all	0 / 42	1 / 41	0 / 60
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic respiratory failure
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cough
subjects affected / exposed	6 / 2347 (0.26%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	1 / 6	0 / 2	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diaphragmatic paralysis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	54 / 2347 (2.30%)	46 / 2348 (1.96%)	35 / 2345 (1.49%)
occurrences causally related to treatment / all	0 / 65	0 / 59	0 / 45
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspnoea at rest
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	1 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspnoea paroxysmal nocturnal
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Emphysema
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	4 / 2347 (0.17%)	3 / 2348 (0.13%)	8 / 2345 (0.34%)
occurrences causally related to treatment / all	0 / 4	0 / 3	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	4 / 2347 (0.17%)	2 / 2348 (0.09%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 4	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hiccups
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydrothorax
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypercapnia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperventilation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Idiopathic pulmonary fibrosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laryngeal oedema
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung infiltration
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mediastinal mass
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nasal septum deviation
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Organising pneumonia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oropharyngeal pain
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Orthopnoea
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngeal oedema
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	10 / 2347 (0.43%)	11 / 2348 (0.47%)	12 / 2345 (0.51%)
occurrences causally related to treatment / all	0 / 13	0 / 13	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pleurocutaneous fistula
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumomediastinum
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	5 / 2347 (0.21%)	6 / 2348 (0.26%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Productive cough
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary alveolar haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary arterial hypertension
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary artery thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary congestion
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	17 / 2347 (0.72%)	18 / 2348 (0.77%)	9 / 2345 (0.38%)
occurrences causally related to treatment / all	0 / 18	0 / 18	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary fibrosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary haematoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	6 / 2347 (0.26%)	4 / 2348 (0.17%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	27 / 2347 (1.15%)	27 / 2348 (1.15%)	14 / 2345 (0.60%)
occurrences causally related to treatment / all	0 / 37	0 / 30	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary venous thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	0 / 2347 (0.00%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	16 / 2347 (0.68%)	16 / 2348 (0.68%)	26 / 2345 (1.11%)
occurrences causally related to treatment / all	0 / 16	0 / 16	2 / 28
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	1 / 3	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Snoring
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suffocation feeling
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vocal cord leukoplakia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Abulia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute psychosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adjustment disorder
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcohol abuse
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anxiety
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anxiety disorder
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Apathy
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bipolar disorder
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Catatonia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Confusional state
subjects affected / exposed	4 / 2347 (0.17%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Delirium
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Delusion
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Depression
subjects affected / exposed	2 / 2347 (0.09%)	6 / 2348 (0.26%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Disorientation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fear
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Insomnia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mood disorder due to a general medical condition
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Restlessness
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Schizophrenia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Somatisation disorder
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Acute hepatic failure
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bile duct obstruction
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bile duct stenosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	3 / 2347 (0.13%)	3 / 2348 (0.13%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Biliary cirrhosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Biliary dilatation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	2 / 2347 (0.09%)	5 / 2348 (0.21%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 4	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholangitis acute
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	7 / 2347 (0.30%)	4 / 2348 (0.17%)	8 / 2345 (0.34%)
occurrences causally related to treatment / all	0 / 7	0 / 4	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	9 / 2347 (0.38%)	9 / 2348 (0.38%)	9 / 2345 (0.38%)
occurrences causally related to treatment / all	0 / 9	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	18 / 2347 (0.77%)	15 / 2348 (0.64%)	13 / 2345 (0.55%)
occurrences causally related to treatment / all	1 / 18	0 / 15	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic hepatitis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cirrhosis alcoholic
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Drug-induced liver injury
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic congestion
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic failure
subjects affected / exposed	4 / 2347 (0.17%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 4	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic function abnormal
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic steatosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatitis acute
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	1 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatitis alcoholic
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatocellular injury
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatomegaly
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatorenal failure
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatorenal syndrome
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatotoxicity
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic hepatitis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Jaundice
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Jaundice cholestatic
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Jaundice hepatocellular
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Liver disorder
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Liver injury
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-alcoholic steatohepatitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Portal hypertension
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Anticoagulation drug level below therapeutic
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anticoagulation drug level increased
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	1 / 1	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	7 / 2347 (0.30%)	4 / 2348 (0.17%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	1 / 8	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood ethanol increased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood glucose increased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood magnesium decreased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood potassium decreased
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood potassium increased
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood urine
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood urine present
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain natriuretic peptide increased
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
C-reactive protein increased
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac murmur
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac output decreased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardioactive drug level increased
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chest X-ray abnormal
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coagulation test abnormal
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coagulation time prolonged
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ejection fraction abnormal
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ejection fraction decreased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Electrocardiogram QRS complex prolonged
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enterobacter test positive
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Heart rate decreased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Heart rate irregular
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
International normalised ratio abnormal
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
International normalised ratio increased
subjects affected / exposed	5 / 2347 (0.21%)	3 / 2348 (0.13%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 5	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lipase increased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oxygen saturation decreased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatic specific antigen increased
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transaminases increased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urine output decreased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral load increased
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	3 / 2347 (0.13%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Weight increased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
White blood cell count increased
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Accident
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Accidental exposure to product
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Accidental overdose
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acetabulum fracture
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anastomotic complication
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anastomotic ulcer
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	0 / 2347 (0.00%)	4 / 2348 (0.17%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Avulsion fracture
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bone contusion
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain contusion
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Burns third degree
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carbon monoxide poisoning
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac function disturbance postoperative
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac procedure complication
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carotid artery restenosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chest injury
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clavicle fracture
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Closed globe injury
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Comminuted fracture
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Complications of transplanted heart
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Concussion
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Contusion
subjects affected / exposed	5 / 2347 (0.21%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery reocclusion
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery restenosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary vascular graft occlusion
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Excoriation
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Extradural haematoma
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fall
subjects affected / exposed	9 / 2347 (0.38%)	8 / 2348 (0.34%)	11 / 2345 (0.47%)
occurrences causally related to treatment / all	0 / 9	0 / 9	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	5 / 2347 (0.21%)	3 / 2348 (0.13%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	9 / 2347 (0.38%)	10 / 2348 (0.43%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 9	0 / 11	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Foreign body
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fracture displacement
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fractured ischium
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fractured sacrum
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal stoma complication
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	7 / 2347 (0.30%)	3 / 2348 (0.13%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	4 / 2347 (0.17%)	5 / 2348 (0.21%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 4	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Incision site haematoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal anastomosis complication
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint injury
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laceration
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ligament injury
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ligament sprain
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Limb injury
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Limb traumatic amputation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lip injury
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mouth injury
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Muscle injury
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Muscle rupture
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Overdose
subjects affected / exposed	4 / 2347 (0.17%)	9 / 2348 (0.38%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 4	1 / 9	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Periorbital haemorrhage
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral artery restenosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Periprosthetic fracture
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumothorax traumatic
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Poisoning
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural bile leak
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural haematuria
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	1 / 2347 (0.04%)	4 / 2348 (0.17%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post-traumatic pain
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postoperative hernia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postoperative ileus
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postoperative thoracic procedure complication
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postoperative wound complication
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Procedural complication
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Product name confusion
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pubis fracture
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary contusion
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	5 / 2347 (0.21%)	5 / 2348 (0.21%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 5	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory fume inhalation disorder
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	8 / 2347 (0.34%)	6 / 2348 (0.26%)	8 / 2345 (0.34%)
occurrences causally related to treatment / all	0 / 8	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sacroiliac fracture
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Scrotal haematoma
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Shunt stenosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin abrasion
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin injury
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Soft tissue injury
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	1 / 2347 (0.04%)	4 / 2348 (0.17%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal cord injury
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	2 / 2347 (0.09%)	5 / 2348 (0.21%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 2	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subdural haemorrhage
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tooth fracture
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	6 / 2347 (0.26%)	3 / 2348 (0.13%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 8	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transplant failure
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Traumatic fracture
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Traumatic haematoma
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Traumatic haemothorax
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Traumatic liver injury
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Traumatic shock
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Underdose
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	1 / 2347 (0.04%)	4 / 2348 (0.17%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urethral stricture traumatic
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular bypass dysfunction
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular graft occlusion
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vasoplegia syndrome
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wound
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wound haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Atrial septal defect
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dermoid cyst
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydrocele
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	6 / 2347 (0.26%)	18 / 2348 (0.77%)	16 / 2345 (0.68%)
occurrences causally related to treatment / all	0 / 6	0 / 19	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute left ventricular failure
subjects affected / exposed	3 / 2347 (0.13%)	5 / 2348 (0.21%)	9 / 2345 (0.38%)
occurrences causally related to treatment / all	0 / 5	0 / 5	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	49 / 2347 (2.09%)	40 / 2348 (1.70%)	46 / 2345 (1.96%)
occurrences causally related to treatment / all	0 / 50	1 / 41	1 / 47
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adams-Stokes syndrome
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	35 / 2347 (1.49%)	33 / 2348 (1.41%)	37 / 2345 (1.58%)
occurrences causally related to treatment / all	0 / 41	1 / 39	1 / 51
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	47 / 2347 (2.00%)	48 / 2348 (2.04%)	41 / 2345 (1.75%)
occurrences causally related to treatment / all	0 / 68	0 / 54	0 / 49
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic valve disease
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	3 / 2347 (0.13%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	13 / 2347 (0.55%)	15 / 2348 (0.64%)	12 / 2345 (0.51%)
occurrences causally related to treatment / all	1 / 13	0 / 17	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arrhythmia supraventricular
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	4 / 2347 (0.17%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	89 / 2347 (3.79%)	98 / 2348 (4.17%)	97 / 2345 (4.14%)
occurrences causally related to treatment / all	0 / 105	1 / 120	0 / 118
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	15 / 2347 (0.64%)	21 / 2348 (0.89%)	11 / 2345 (0.47%)
occurrences causally related to treatment / all	1 / 17	0 / 25	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	1 / 2347 (0.04%)	4 / 2348 (0.17%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrial thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	7 / 2347 (0.30%)	8 / 2348 (0.34%)	13 / 2345 (0.55%)
occurrences causally related to treatment / all	0 / 7	1 / 8	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular block first degree
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	3 / 2347 (0.13%)	4 / 2348 (0.17%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 3	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bifascicular block
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bradyarrhythmia
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	12 / 2347 (0.51%)	12 / 2348 (0.51%)	9 / 2345 (0.38%)
occurrences causally related to treatment / all	0 / 12	2 / 13	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bundle branch block
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bundle branch block left
subjects affected / exposed	4 / 2347 (0.17%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 4	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac aneurysm
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	59 / 2347 (2.51%)	61 / 2348 (2.60%)	59 / 2345 (2.52%)
occurrences causally related to treatment / all	0 / 63	0 / 63	3 / 62
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac asthma
subjects affected / exposed	2 / 2347 (0.09%)	4 / 2348 (0.17%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac discomfort
subjects affected / exposed	3 / 2347 (0.13%)	3 / 2348 (0.13%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorder
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	480 / 2347 (20.45%)	521 / 2348 (22.19%)	503 / 2345 (21.45%)
occurrences causally related to treatment / all	15 / 892	17 / 996	20 / 903
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	54 / 2347 (2.30%)	43 / 2348 (1.83%)	60 / 2345 (2.56%)
occurrences causally related to treatment / all	1 / 75	1 / 56	2 / 80
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac failure chronic
subjects affected / exposed	120 / 2347 (5.11%)	125 / 2348 (5.32%)	122 / 2345 (5.20%)
occurrences causally related to treatment / all	3 / 209	3 / 189	8 / 220
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	76 / 2347 (3.24%)	85 / 2348 (3.62%)	79 / 2345 (3.37%)
occurrences causally related to treatment / all	3 / 123	4 / 136	1 / 140
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac flutter
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac hypertrophy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac perforation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac sarcoidosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac tamponade
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac valve disease
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac ventricular thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	24 / 2347 (1.02%)	24 / 2348 (1.02%)	20 / 2345 (0.85%)
occurrences causally related to treatment / all	1 / 24	3 / 24	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiogenic shock
subjects affected / exposed	31 / 2347 (1.32%)	49 / 2348 (2.09%)	38 / 2345 (1.62%)
occurrences causally related to treatment / all	1 / 32	2 / 52	0 / 44
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiomegaly
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	4 / 2347 (0.17%)	6 / 2348 (0.26%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 4	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiorenal syndrome
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiovascular disorder
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiovascular insufficiency
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chordae tendinae rupture
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronotropic incompetence
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	14 / 2347 (0.60%)	14 / 2348 (0.60%)	19 / 2345 (0.81%)
occurrences causally related to treatment / all	0 / 15	0 / 14	0 / 22
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	28 / 2347 (1.19%)	27 / 2348 (1.15%)	22 / 2345 (0.94%)
occurrences causally related to treatment / all	0 / 31	1 / 29	0 / 25
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery insufficiency
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	8 / 2347 (0.34%)	5 / 2348 (0.21%)	8 / 2345 (0.34%)
occurrences causally related to treatment / all	0 / 8	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Extrasystoles
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Heart valve incompetence
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertensive heart disease
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	13 / 2347 (0.55%)	7 / 2348 (0.30%)	13 / 2345 (0.55%)
occurrences causally related to treatment / all	0 / 13	0 / 8	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Left ventricular dysfunction
subjects affected / exposed	6 / 2347 (0.26%)	6 / 2348 (0.26%)	8 / 2345 (0.34%)
occurrences causally related to treatment / all	0 / 7	0 / 6	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	6 / 2347 (0.26%)	5 / 2348 (0.21%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 7	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolic cardiomyopathy
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	6 / 2347 (0.26%)	17 / 2348 (0.72%)	14 / 2345 (0.60%)
occurrences causally related to treatment / all	0 / 6	0 / 19	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mitral valve prolapse
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mitral valve stenosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	56 / 2347 (2.39%)	50 / 2348 (2.13%)	50 / 2345 (2.13%)
occurrences causally related to treatment / all	1 / 63	0 / 51	0 / 57
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	19 / 2347 (0.81%)	19 / 2348 (0.81%)	18 / 2345 (0.77%)
occurrences causally related to treatment / all	0 / 20	1 / 19	0 / 21
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nodal rhythm
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Palpitations
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Papillary muscle rupture
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary valve incompetence
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulseless electrical activity
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Restrictive cardiomyopathy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rhythm idioventricular
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Right ventricular failure
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	1 / 2	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinoatrial block
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinus arrhythmia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	6 / 2347 (0.26%)	3 / 2348 (0.13%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 6	1 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Supraventricular extrasystoles
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Supraventricular tachyarrhythmia
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	7 / 2347 (0.30%)	5 / 2348 (0.21%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Systolic dysfunction
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tachyarrhythmia
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	9 / 2347 (0.38%)	5 / 2348 (0.21%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	1 / 10	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tachycardia paroxysmal
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tricuspid valve disease
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tricuspid valve incompetence
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	14 / 2347 (0.60%)	8 / 2348 (0.34%)	14 / 2345 (0.60%)
occurrences causally related to treatment / all	0 / 16	0 / 8	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular dysfunction
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular dyssynchrony
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	8 / 2347 (0.34%)	9 / 2348 (0.38%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	1 / 8	0 / 9	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular failure
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	32 / 2347 (1.36%)	30 / 2348 (1.28%)	34 / 2345 (1.45%)
occurrences causally related to treatment / all	2 / 33	2 / 33	1 / 37
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular flutter
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular tachyarrhythmia
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	78 / 2347 (3.32%)	67 / 2348 (2.85%)	63 / 2345 (2.69%)
occurrences causally related to treatment / all	2 / 97	2 / 92	0 / 75
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Ageusia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Altered state of consciousness
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Amyotrophic lateral sclerosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aphasia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atonic seizures
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Balance disorder
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Basilar artery stenosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain hypoxia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain injury
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain oedema
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain stem infarction
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain stem syndrome
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carotid arteriosclerosis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carotid artery disease
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	3 / 2347 (0.13%)	5 / 2348 (0.21%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebellar ataxia
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebellar haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebellar infarction
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral amyloid angiopathy
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral arteriosclerosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral artery embolism
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral artery occlusion
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral atrophy
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral haematoma
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	6 / 2347 (0.26%)	9 / 2348 (0.38%)	7 / 2345 (0.30%)
occurrences causally related to treatment / all	0 / 6	0 / 9	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	9 / 2347 (0.38%)	17 / 2348 (0.72%)	17 / 2345 (0.72%)
occurrences causally related to treatment / all	0 / 10	1 / 17	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral ischaemia
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	44 / 2347 (1.87%)	51 / 2348 (2.17%)	62 / 2345 (2.64%)
occurrences causally related to treatment / all	1 / 48	0 / 53	2 / 69
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebrovascular disorder
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebrovascular insufficiency
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cervicogenic headache
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coma
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Complex partial seizures
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dementia
subjects affected / exposed	6 / 2347 (0.26%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Depressed level of consciousness
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic coma
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic hyperosmolar coma
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic neuropathy
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dizziness
subjects affected / exposed	11 / 2347 (0.47%)	9 / 2348 (0.38%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	1 / 11	0 / 10	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dizziness postural
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyslalia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Embolic cerebral infarction
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Encephalomalacia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	2 / 2347 (0.09%)	7 / 2348 (0.30%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	3 / 2347 (0.13%)	4 / 2348 (0.17%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Headache
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hemianopia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hemianopia homonymous
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	3 / 2347 (0.13%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hemiplegia
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic encephalopathy
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoglycaemic coma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoglycaemic seizure
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 2	1 / 2	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
IIIrd nerve paresis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intraventricular haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic cerebral infarction
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	45 / 2347 (1.92%)	45 / 2348 (1.92%)	29 / 2345 (1.24%)
occurrences causally related to treatment / all	1 / 47	0 / 51	0 / 30
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lacunar infarction
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Leukoencephalopathy
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	5 / 2347 (0.21%)	3 / 2348 (0.13%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 5	1 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mental retardation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Monoparesis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Monoplegia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Motor neurone disease
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myoclonus
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Narcolepsy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorder
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Orthostatic intolerance
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Paraparesis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Paresis cranial nerve
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Parkinson's disease
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Parkinsonism
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Partial seizures
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral sensory neuropathy
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postresuscitation encephalopathy
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Presyncope
subjects affected / exposed	4 / 2347 (0.17%)	5 / 2348 (0.21%)	9 / 2345 (0.38%)
occurrences causally related to treatment / all	1 / 4	0 / 5	1 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychomotor hyperactivity
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Restless legs syndrome
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retrograde amnesia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reversible ischaemic neurological deficit
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sciatica
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	1 / 2347 (0.04%)	4 / 2348 (0.17%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Somnolence
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal claudication
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal epidural haematoma
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	48 / 2347 (2.05%)	56 / 2348 (2.39%)	27 / 2345 (1.15%)
occurrences causally related to treatment / all	5 / 58	7 / 71	1 / 31
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tension headache
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thalamus haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	23 / 2347 (0.98%)	20 / 2348 (0.85%)	15 / 2345 (0.64%)
occurrences causally related to treatment / all	0 / 23	0 / 20	1 / 18
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tremor
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Trigeminal nerve disorder
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Uraemic encephalopathy
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
VIIth nerve paralysis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular dementia
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular encephalopathy
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vertebrobasilar insufficiency
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	1 / 3	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Acquired haemophilia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaemia
subjects affected / exposed	36 / 2347 (1.53%)	28 / 2348 (1.19%)	28 / 2345 (1.19%)
occurrences causally related to treatment / all	2 / 39	0 / 40	1 / 31
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaemia vitamin B12 deficiency
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aplastic anaemia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bicytopenia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bone marrow infiltration
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coagulopathy
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemolytic anaemia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhagic anaemia
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhagic diathesis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypochromic anaemia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypocoagulable state
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Jaundice acholuric
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphadenitis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphadenopathy mediastinal
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Normochromic normocytic anaemia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	4 / 2347 (0.17%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	1 / 7	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Polycythaemia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retroperitoneal lymphadenopathy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Splenic embolism
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Splenic infarction
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Splenic vein thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Deafness neurosensory
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Deafness unilateral
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematotympanum
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meniere's disease
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sudden hearing loss
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tympanic membrane perforation
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vertigo
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	1 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye disorders
Amaurosis fugax
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Amblyopia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cataract
subjects affected / exposed	13 / 2347 (0.55%)	8 / 2348 (0.34%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 16	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Conjunctival haemorrhage
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic retinopathy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Macular hole
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ocular fistula
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ocular retrobulbar haemorrhage
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ophthalmic vein thrombosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinal artery embolism
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinal degeneration
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinal vein occlusion
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Retinopathy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Visual acuity reduced
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal adhesions
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal discomfort
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal distension
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	14 / 2347 (0.60%)	10 / 2348 (0.43%)	11 / 2345 (0.47%)
occurrences causally related to treatment / all	0 / 16	0 / 23	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	4 / 2347 (0.17%)	5 / 2348 (0.21%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal strangulated hernia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acid peptic disease
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute abdomen
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcoholic pancreatitis
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal prolapse
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ascites
subjects affected / exposed	6 / 2347 (0.26%)	6 / 2348 (0.26%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 13	0 / 6	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Autoimmune pancreatitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic gastritis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed	6 / 2347 (0.26%)	5 / 2348 (0.21%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	1 / 7	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dental caries
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic gastroparesis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	18 / 2347 (0.77%)	4 / 2348 (0.17%)	11 / 2345 (0.47%)
occurrences causally related to treatment / all	1 / 20	0 / 4	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dieulafoy's vascular malformation
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenal ulcer
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenal ulcer perforation
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	4 / 2347 (0.17%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enteritis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enterocolitis
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enterovesical fistula
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eosinophilic oesophagitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epigastric discomfort
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Erosive duodenitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Erosive oesophagitis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Faecaloma
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femoral hernia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Femoral hernia, obstructive
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric polyps
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	7 / 2347 (0.30%)	4 / 2348 (0.17%)	8 / 2345 (0.34%)
occurrences causally related to treatment / all	0 / 7	0 / 4	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	6 / 2347 (0.26%)	2 / 2348 (0.09%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 6	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric ulcer perforation
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	10 / 2347 (0.43%)	4 / 2348 (0.17%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 10	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	1 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis haemorrhagic
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroduodenal ulcer
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	19 / 2347 (0.81%)	13 / 2348 (0.55%)	11 / 2345 (0.47%)
occurrences causally related to treatment / all	0 / 19	1 / 14	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal inflammation
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal ischaemia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal necrosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal polyp haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal ulcer
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gingival bleeding
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhagic erosive gastritis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	1 / 2347 (0.04%)	4 / 2348 (0.17%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	0 / 2347 (0.00%)	5 / 2348 (0.21%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ileus
subjects affected / exposed	4 / 2347 (0.17%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 5	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Incarcerated inguinal hernia
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Incarcerated umbilical hernia
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	23 / 2347 (0.98%)	21 / 2348 (0.89%)	14 / 2345 (0.60%)
occurrences causally related to treatment / all	1 / 23	0 / 21	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal fistula
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal infarction
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal polyp
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal strangulation
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Irritable bowel syndrome
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large intestinal stenosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	2 / 2347 (0.09%)	5 / 2348 (0.21%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 5	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Melaena
subjects affected / exposed	3 / 2347 (0.13%)	4 / 2348 (0.17%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mesenteric artery embolism
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mesenteric artery thrombosis
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mesenteritis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mouth haemorrhage
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	5 / 2347 (0.21%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 4	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oedematous pancreatitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal ulcer
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal ulcer haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophagitis haemorrhagic
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatic cyst
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	5 / 2347 (0.21%)	4 / 2348 (0.17%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 5	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	9 / 2347 (0.38%)	5 / 2348 (0.21%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	1 / 9	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis necrotising
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peptic ulcer
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peptic ulcer haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peptic ulcer perforation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngo-oesophageal diverticulum
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Portal hypertensive gastropathy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Proctalgia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Proctitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	7 / 2347 (0.30%)	5 / 2348 (0.21%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 8	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal prolapse
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Stress ulcer
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subileus
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombosis mesenteric vessel
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tongue oedema
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tooth disorder
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	5 / 2347 (0.21%)	5 / 2348 (0.21%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 6	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	6 / 2347 (0.26%)	12 / 2348 (0.51%)	7 / 2345 (0.30%)
occurrences causally related to treatment / all	0 / 6	1 / 12	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Visceral congestion
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Volvulus
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Volvulus of small bowel
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	5 / 2347 (0.21%)	5 / 2348 (0.21%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 6	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Acquired epidermolysis bullosa
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Actinic keratosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Angioedema
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Decubitus ulcer
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dermal cyst
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dermatitis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dermatitis allergic
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dermatitis bullous
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dermatitis contact
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	5 / 2347 (0.21%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic ulcer
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Drug eruption
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ecchymosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Erythema
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fungating wound
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Henoch-Schonlein purpura
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperhidrosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intertrigo
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lichen sclerosus
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neuropathic ulcer
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peau d'orange
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Precancerous skin lesion
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pruritus
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Purpura
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rash
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Seborrhoeic dermatitis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin necrosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	4 / 2347 (0.17%)	4 / 2348 (0.17%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin ulcer haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Toxic skin eruption
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	52 / 2347 (2.22%)	29 / 2348 (1.24%)	38 / 2345 (1.62%)
occurrences causally related to treatment / all	12 / 60	5 / 31	1 / 41
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute prerenal failure
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	1 / 1	2 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anuria
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Azotaemia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Calculus bladder
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Calculus ureteric
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Calculus urethral
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	21 / 2347 (0.89%)	10 / 2348 (0.43%)	10 / 2345 (0.43%)
occurrences causally related to treatment / all	6 / 24	0 / 10	3 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic nephropathy
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dysuria
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Glomerulonephritis membranous
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematuria
subjects affected / exposed	4 / 2347 (0.17%)	6 / 2348 (0.26%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 4	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertensive nephropathy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic nephropathy
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephritis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephropathy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Polyuria
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postrenal failure
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prerenal failure
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Proteinuria
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal disorder
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal embolism
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	33 / 2347 (1.41%)	26 / 2348 (1.11%)	27 / 2345 (1.15%)
occurrences causally related to treatment / all	6 / 34	4 / 26	4 / 29
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	34 / 2347 (1.45%)	31 / 2348 (1.32%)	33 / 2345 (1.41%)
occurrences causally related to treatment / all	9 / 36	8 / 33	8 / 33
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal infarct
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ureteric fistula
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ureteric stenosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urethral obstruction
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary bladder haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary bladder polyp
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	3 / 2347 (0.13%)	7 / 2348 (0.30%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 3	1 / 9	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinoma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endocrine disorders
Goitre
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperthyroidism
subjects affected / exposed	2 / 2347 (0.09%)	5 / 2348 (0.21%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	1 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	2 / 2347 (0.09%)	7 / 2348 (0.30%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyrotoxic crisis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Toxic nodular goitre
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	6 / 2347 (0.26%)	3 / 2348 (0.13%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arthritis
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	4 / 2347 (0.17%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 4	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bursitis
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chondropathy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Compartment syndrome
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Connective tissue inflammation
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic amyotrophy
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fistula
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Flank pain
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fracture malunion
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	6 / 2347 (0.26%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 7	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint effusion
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint instability
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Muscle atrophy
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Muscle haemorrhage
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	0 / 2347 (0.00%)	5 / 2348 (0.21%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal stiffness
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myalgia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myopathy
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myopathy toxic
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myositis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neck pain
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteitis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	9 / 2347 (0.38%)	12 / 2348 (0.51%)	10 / 2345 (0.43%)
occurrences causally related to treatment / all	0 / 9	0 / 15	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteochondritis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteonecrosis of jaw
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoporosis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoporotic fracture
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	4 / 2347 (0.17%)	3 / 2348 (0.13%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 5	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Polyarthritis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rheumatic disorder
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	0 / 2347 (0.00%)	4 / 2348 (0.17%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Scleroderma
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal column stenosis
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal deformity
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal pain
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal infection
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal sepsis
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess intestinal
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess jaw
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess oral
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acinetobacter infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Appendiceal abscess
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	5 / 2347 (0.21%)	2 / 2348 (0.09%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 5	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	1 / 2347 (0.04%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atypical pneumonia
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bacterial diarrhoea
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Biliary sepsis
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bone abscess
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bone tuberculosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain abscess
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	22 / 2347 (0.94%)	16 / 2348 (0.68%)	11 / 2345 (0.47%)
occurrences causally related to treatment / all	0 / 26	0 / 16	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis bacterial
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Burn infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bursitis infective
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Campylobacter gastroenteritis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac valve abscess
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	6 / 2347 (0.26%)	9 / 2348 (0.38%)	13 / 2345 (0.55%)
occurrences causally related to treatment / all	0 / 7	0 / 12	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic sinusitis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clostridial infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Corynebacterium infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cystitis
subjects affected / exposed	6 / 2347 (0.26%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 6	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cytomegalovirus infection
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device related infection
subjects affected / exposed	6 / 2347 (0.26%)	6 / 2348 (0.26%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 10	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Device related sepsis
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	6 / 2347 (0.26%)	0 / 2348 (0.00%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dysentery
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Empyema
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Encephalitis
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	5 / 2347 (0.21%)	5 / 2348 (0.21%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 5	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endocarditis bacterial
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endocarditis staphylococcal
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enteritis infectious
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enterococcal sepsis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	6 / 2347 (0.26%)	7 / 2348 (0.30%)	10 / 2345 (0.43%)
occurrences causally related to treatment / all	0 / 6	0 / 7	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Escherichia infection
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Febrile infection
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fungal oesophagitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gangrene
subjects affected / exposed	10 / 2347 (0.43%)	3 / 2348 (0.13%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 12	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastric ulcer helicobacter
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	13 / 2347 (0.55%)	10 / 2348 (0.43%)	16 / 2345 (0.68%)
occurrences causally related to treatment / all	0 / 13	1 / 10	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis clostridial
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis norovirus
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Genitourinary tract infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
H1N1 influenza
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematoma infection
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemophilus sepsis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Helicobacter infection
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic infection bacterial
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatitis B
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatitis viral
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes zoster cutaneous disseminated
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Human ehrlichiosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Implant site infection
subjects affected / exposed	3 / 2347 (0.13%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Incision site abscess
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Incision site infection
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infected cyst
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infected seroma
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	2 / 2347 (0.09%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 2	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infection
subjects affected / exposed	4 / 2347 (0.17%)	2 / 2348 (0.09%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 4	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infectious colitis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infectious pleural effusion
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	1 / 2347 (0.04%)	4 / 2348 (0.17%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	2 / 2347 (0.09%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intervertebral discitis
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal sepsis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Localised infection
subjects affected / exposed	5 / 2347 (0.21%)	4 / 2348 (0.17%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	5 / 2347 (0.21%)	6 / 2348 (0.26%)	9 / 2345 (0.38%)
occurrences causally related to treatment / all	0 / 6	0 / 7	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung abscess
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung infection
subjects affected / exposed	10 / 2347 (0.43%)	6 / 2348 (0.26%)	13 / 2345 (0.55%)
occurrences causally related to treatment / all	0 / 10	0 / 9	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lyme disease
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mucormycosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mycobacterial infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myiasis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nasopharyngitis
subjects affected / exposed	3 / 2347 (0.13%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ophthalmic herpes zoster
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oral fungal infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oral infection
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Orchitis
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oropharyngitis fungal
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Otitis media acute
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Parametritis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Paronychia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Periodontitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	2 / 2347 (0.09%)	3 / 2348 (0.13%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 2	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonitis bacterial
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumococcal sepsis
subjects affected / exposed	2 / 2347 (0.09%)	5 / 2348 (0.21%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 2	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumocystis jirovecii infection
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	136 / 2347 (5.79%)	145 / 2348 (6.18%)	122 / 2345 (5.20%)
occurrences causally related to treatment / all	1 / 164	0 / 176	0 / 146
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia escherichia
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia haemophilus
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia mycoplasmal
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia pneumococcal
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia pseudomonal
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia staphylococcal
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural sepsis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostatic abscess
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pseudomembranous colitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pseudomonal sepsis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pseudomonas infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psoas abscess
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary sepsis
subjects affected / exposed	8 / 2347 (0.34%)	6 / 2348 (0.26%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 8	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	4 / 2347 (0.17%)	3 / 2348 (0.13%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis chronic
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal abscess
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	8 / 2347 (0.34%)	15 / 2348 (0.64%)	19 / 2345 (0.81%)
occurrences causally related to treatment / all	1 / 8	0 / 19	0 / 20
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory tract infection bacterial
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory tract infection fungal
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory tract infection viral
subjects affected / exposed	1 / 2347 (0.04%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	14 / 2347 (0.60%)	18 / 2348 (0.77%)	12 / 2345 (0.51%)
occurrences causally related to treatment / all	0 / 15	0 / 19	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Septic necrosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Septic shock
subjects affected / exposed	13 / 2347 (0.55%)	21 / 2348 (0.89%)	13 / 2345 (0.55%)
occurrences causally related to treatment / all	0 / 13	0 / 21	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sialoadenitis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin bacterial infection
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin infection
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Soft tissue infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal cord infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Streptococcal endocarditis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Streptococcal sepsis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombophlebitis septic
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tooth infection
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tracheitis
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	6 / 2347 (0.26%)	5 / 2348 (0.21%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 8	1 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	4 / 2347 (0.17%)	5 / 2348 (0.21%)	6 / 2345 (0.26%)
occurrences causally related to treatment / all	0 / 4	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection bacterial
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urethritis
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	22 / 2347 (0.94%)	21 / 2348 (0.89%)	19 / 2345 (0.81%)
occurrences causally related to treatment / all	0 / 25	0 / 22	0 / 19
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection bacterial
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection pseudomonal
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	5 / 2347 (0.21%)	7 / 2348 (0.30%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 5	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	0 / 2347 (0.00%)	3 / 2348 (0.13%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral pericarditis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral vasculitis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wound infection
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wound infection bacterial
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wound infection staphylococcal
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Wound sepsis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Acidosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cachexia
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Carbohydrate intolerance
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Decreased appetite
subjects affected / exposed	7 / 2347 (0.30%)	6 / 2348 (0.26%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 9	2 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dehydration
subjects affected / exposed	27 / 2347 (1.15%)	21 / 2348 (0.89%)	14 / 2345 (0.60%)
occurrences causally related to treatment / all	1 / 30	0 / 24	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	15 / 2347 (0.64%)	16 / 2348 (0.68%)	10 / 2345 (0.43%)
occurrences causally related to treatment / all	1 / 16	0 / 16	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	7 / 2347 (0.30%)	6 / 2348 (0.26%)	4 / 2345 (0.17%)
occurrences causally related to treatment / all	0 / 7	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 3	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fluid overload
subjects affected / exposed	3 / 2347 (0.13%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fluid retention
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Glucose tolerance impaired
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gout
subjects affected / exposed	11 / 2347 (0.47%)	11 / 2348 (0.47%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 13	1 / 14	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	2 / 2347 (0.09%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	6 / 2347 (0.26%)	1 / 2348 (0.04%)	3 / 2345 (0.13%)
occurrences causally related to treatment / all	0 / 7	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	21 / 2347 (0.89%)	13 / 2348 (0.55%)	20 / 2345 (0.85%)
occurrences causally related to treatment / all	12 / 22	6 / 14	11 / 22
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperosmolar hyperglycaemic state
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperosmolar state
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypertriglyceridaemia
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperuricaemia
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypervolaemia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoalbuminaemia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	10 / 2347 (0.43%)	5 / 2348 (0.21%)	5 / 2345 (0.21%)
occurrences causally related to treatment / all	0 / 12	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	10 / 2347 (0.43%)	12 / 2348 (0.51%)	10 / 2345 (0.43%)
occurrences causally related to treatment / all	0 / 10	0 / 14	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	5 / 2347 (0.21%)	7 / 2348 (0.30%)	10 / 2345 (0.43%)
occurrences causally related to treatment / all	0 / 5	0 / 10	1 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypophagia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoproteinaemia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	0 / 2347 (0.00%)	2 / 2348 (0.09%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Insulin resistance
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Iron deficiency
subjects affected / exposed	0 / 2347 (0.00%)	1 / 2348 (0.04%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ketoacidosis
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Marasmus
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	2 / 2347 (0.09%)	0 / 2348 (0.00%)	2 / 2345 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolic disorder
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mineral deficiency
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Obesity
subjects affected / exposed	1 / 2347 (0.04%)	0 / 2348 (0.00%)	0 / 2345 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Polydipsia
subjects affected / exposed	0 / 2347 (0.00%)	0 / 2348 (0.00%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Type 1 diabetes mellitus
subjects affected / exposed	1 / 2347 (0.04%)	1 / 2348 (0.04%)	1 / 2345 (0.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	12 / 2347 (0.51%)	10 / 2348 (0.43%)	8 / 2345 (0.34%)
occurrences causally related to treatment / all	0 / 12	0 / 11	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Combination	Aliskiren	Enalapril
Total subjects affected by non serious adverse events
subjects affected / exposed	1548 / 2347 (65.96%)	1446 / 2348 (61.58%)	1458 / 2345 (62.17%)
Vascular disorders
Hypertension
subjects affected / exposed	188 / 2347 (8.01%)	180 / 2348 (7.67%)	137 / 2345 (5.84%)
occurrences all number	248	220	172
Hypotension
subjects affected / exposed	409 / 2347 (17.43%)	308 / 2348 (13.12%)	332 / 2345 (14.16%)
occurrences all number	618	403	439
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	199 / 2347 (8.48%)	238 / 2348 (10.14%)	184 / 2345 (7.85%)
occurrences all number	235	292	220
Cardiac failure
subjects affected / exposed	241 / 2347 (10.27%)	254 / 2348 (10.82%)	238 / 2345 (10.15%)
occurrences all number	349	359	362
Nervous system disorders
Dizziness
subjects affected / exposed	179 / 2347 (7.63%)	140 / 2348 (5.96%)	144 / 2345 (6.14%)
occurrences all number	230	173	185
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	124 / 2347 (5.28%)	115 / 2348 (4.90%)	111 / 2345 (4.73%)
occurrences all number	141	120	118
General disorders and administration site conditions
Oedema peripheral
subjects affected / exposed	182 / 2347 (7.75%)	183 / 2348 (7.79%)	176 / 2345 (7.51%)
occurrences all number	233	241	216
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	145 / 2347 (6.18%)	117 / 2348 (4.98%)	116 / 2345 (4.95%)
occurrences all number	171	124	131
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	285 / 2347 (12.14%)	223 / 2348 (9.50%)	286 / 2345 (12.20%)
occurrences all number	372	281	354
Dyspnoea
subjects affected / exposed	204 / 2347 (8.69%)	216 / 2348 (9.20%)	213 / 2345 (9.08%)
occurrences all number	268	318	274
Renal and urinary disorders
Renal impairment
subjects affected / exposed	414 / 2347 (17.64%)	298 / 2348 (12.69%)	328 / 2345 (13.99%)
occurrences all number	564	381	451
Infections and infestations
Bronchitis
subjects affected / exposed	151 / 2347 (6.43%)	138 / 2348 (5.88%)	147 / 2345 (6.27%)
occurrences all number	179	182	190
Nasopharyngitis
subjects affected / exposed	185 / 2347 (7.88%)	187 / 2348 (7.96%)	186 / 2345 (7.93%)
occurrences all number	270	261	265
Metabolism and nutrition disorders
Hyperkalaemia
subjects affected / exposed	469 / 2347 (19.98%)	283 / 2348 (12.05%)	350 / 2345 (14.93%)
occurrences all number	717	387	481
Hypokalaemia
subjects affected / exposed	130 / 2347 (5.54%)	149 / 2348 (6.35%)	116 / 2345 (4.95%)
occurrences all number	178	223	157

More information

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Were there any global substantial amendments to the protocol? Yes

20 Jan 2010

Amendment 1: The rationale of this amendment was to evaluate a non-invasive technique (BPro™ device) to measure central aortic pressure (CAP) in a representative subset of patients with chronic heart failure (NYHA Class II – IV) from the ATMOSPHERE population

29 Oct 2010

Amendment 2: This protocol amendment mainly served to add the contraindication for itraconazole and to allow the assessment of NT-proBNP at screening instead of BNP. Contraindication of itraconazole was added according to RMP (Risk Management Plan) requirement as it was observed that exposure to aliskiren was increased by the coadministration of cyclosporine and itraconazole. Therefore, concomitant use of aliskiren with potent inhibitors of p-glycoprotein (Pgp) (such as cyclosporine and itraconazole) is not recommended. Inclusion of patients with increased N-terminal pro-brain natriuretic peptide (NT-proBNP) was allowed in addition to patients with increased brain natriuretic peptide (BNP) as it appeared that some sites had only the possibility to measure NT-proBNP but not BNP.

30 Mar 2012

Amendment 3: The rationale of this local protocol amendment, which was only applicable for Costa Rica, followed a request from the local ethics committee to monitor fasting plasma glucose and HbA1c levels in all patients during the course of the trial.

30 Apr 2013

Amendment 4: This protocol amendment followed the request made by the CTFG on behalf of the HAs from the EU member states, after the submission of the ASTRONAUT study FIR to the HAs. Based on these results, the CTFG requested on 12-Feb-2013 that in the EU member states participating to the study, study drug be discontinued in all patients enrolled in ATMOSPHERE who have diabetes (but patients were to remain in the study and be followed up until trial end according to the study protocol), and no new patients with diabetes were allowed to be enrolled in the trial. Novartis complied with this request and amended the protocol to implement these changes consistently, across all participating countries worldwide. Other changes included in this amendment were to change from BNP to NT-proBNP in the analysis, which has the same clinical meaning but has a better chemical stability. Further, the statistical section was updated particularly in regard to the inclusion of an additional hypothesis (aliskiren/enalapril combination compared to enalapril monotherapy in nondiabetic patients), censoring rules for the time to event analysis and refinement in secondary objectives. One of the two secondary objectives (to evaluate whether aliskiren monotherapy and/or the combination of aliskiren/enalapril is superior to enalapril monotherapy in reducing the BNP level from baseline to predefined timepoint) was removed.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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